DP-20 AND DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM

K113153 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYO · Nov 28, 2011 · Radiology

Device Facts

• Record ID: K113153
• Device Name: DP-20 AND DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: IYO · Radiology
• Decision Date: Nov 28, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, intraoperative(abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), cardiac(adult, pediatric), peripheral vascular and urology exams.

Device Story

Portable/mobile digital ultrasonic diagnostic imaging systems (DP-20, DP-30); acquire/display ultrasound data in B-Mode, M-Mode, or B+M Mode. Operated by clinicians in various clinical settings. Uses linear and convex array transducers (2.0-12.0 MHz). Provides real-time imaging for diagnostic exams; supports biopsy guidance and tissue harmonic imaging (no contrast agents). Output displayed on system monitor for physician interpretation; aids in clinical diagnosis and patient management.

Clinical Evidence

Bench testing only. Evaluated for acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, and mechanical safety. Conforms to UD 2, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4, ISO 10993-1, and IEC 62304.

Technological Characteristics

Portable/mobile ultrasound systems; B, M, and B+M modes. Frequency range: 2.0-10.0 MHz (DP-20) and 2.0-12.0 MHz (DP-30). Linear and convex array transducers. Software-controlled. Standards: IEC 60601-1 (safety), IEC 60601-2-37 (ultrasound), ISO 10993-1 (biocompatibility), IEC 62304 (software).

Indications for Use

Indicated for adults, pregnant women, pediatric patients, and neonates. Clinical applications include fetal, abdominal, intraoperative (abdominal, thoracic, vascular), pediatric, small organ (breast, thyroid, testes), neonatal/adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vascular, and urology exams.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Mindray DP-6900 Digital Ultrasonic Diagnostic Imaging System (K090912)
• M5 Diagnostic Ultrasound System (K102991)
• M7 Diagnostic Ultrasound System (K103677)

Submission Summary (Full Text)

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KII3/53

NOV 28 2011

# 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92(c).

The assigned 510(k) number is: K 1 1 153.

### 1. Submitter:

Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China

Tel: [phone] Fax: [phone]

### Contact Person:

Tan Chuanbin Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China

Date Prepared: October 10th, 2011

### 2. Device Name:

DP-20 Digital Ultrasonic Diagnostic Imaging System (new added sub-model) DP-30 Digital Ultrasonic Diagnostic Imaging System (new added sub-model)

### Classification

Regulatory Class: II 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-IYO) 21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)

### 3. Device Description:

The DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System are general purpose, portable/mobile {with mobile ultrasound trolley}, software controlled, ultrasonic diagnostic systems. Its function is to acquire and display ultrasound data in B-Mode,

{1}------------------------------------------------

M-Mode, or their combined mode B+M Mode. The systems are Track 1 device that employs an array of transducers including linear array and convex array. The frequency range of DP-20 is approximately 2.0 MHz to 10.0 MHz and that of DP-30 is approximately 2.0 MHz to 12.0 MHz.

### 4. Intended Use:

The DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, intraoperative(abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal cephalic, trans-rectal, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), cardiac(adult, pediatric), peripheral vascular and urology exams.

### 5. Comparison with Predicate Device:

DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System is comparable with and substantially equivalent to the Mindray DP-6900 Digital Ultrasonic Diagnostic Imaging System (K090912), M5 Diagnostic Ultrasound System(K102991) and M7 Diagnostic Ultrasound System(K103677). They have the same technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes as the predicate device.

### 6. Non-clinical Tests:

DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical safety standards. This device has been designed to meet the following standards: UD 2, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4, ISO 10993-1 and IEC 62304.

### Conclusion:

Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination. The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards. Therefore, the DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System is substantially equivalent with respect to safety and effectiveness to devices

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, with three human profiles incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

DEC -6 2011

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Ms. Susan D. Goldstein-Falk Official Correspondent MDI Consultants. Inc. 55 Northern Blvd, Suite 200 GREAT NECK NY 11021

Re: K113153

Trade/Device Name: DP-20, DP-30 Digital Ultrasonic Diagnostic Imaging System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: October 10, 2011 Received: October 25, 2011

Dear Ms. Goldstein-Falk:

This letter corrects our substantially equivalent letter of November 28, 2011.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the DP-20, DP-30 Digital Ultrasonic Diagnostic Imaging System, as described in your premarket notification:

### Transducer Model Number

| 35C20EA | 65EC10EB | 75L53EA |
|---------|----------|----------|
| 35C50EB | 65EL60EA | 75LT38EA |
| 65C15EA | 75L38EB | 35C20EA |

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| 35C50EA<br>65C15EA<br>65EC10EA<br>65EL60EA | 65EB10EA<br>65EC10ED<br>75L38EA<br>75L53EA | 75LT38EA<br>10L24EA |
|--------------------------------------------|--------------------------------------------|---------------------|
|--------------------------------------------|--------------------------------------------|---------------------|

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Lauren Hefner at [phone].

Sincerely yours.

Michael D. O'Hare for

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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### NOV. 29. 2011 3:13PM

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## Indications for Use

- : 510(k) Number (if known):
Device Name: DP-20, DP-30 Digital Ultrasonic Diagnostic Imaging System

Indications for Use:

The DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, intraoperative (abdominal, thoracic, and vascular), pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vascular and urology.

AND/OR Over - The - Counter Use Prescription Use X (21 CFR Part 801 Subpart D) (21 CFR Part B07 Support C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Sussan D. Galdeterin-Falk

BABSCOPED DO TH FAX FAX [phone]

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# NOV. 29. 2011 3:13PM

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Diagnostic Uttrasound Indications for Use Form Transdiscer x |

System Modol: 510(k) Number(a)

DP-20 KITSTED

| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
|----------------------------------------------------------------------------|---|---|-----|-----|---------------|-------------------|--------------------|-----------------|
| Ophthalmic | | | | | | | | |
| Fetal | N | N | | | | | N | Note 1, Note2 |
| Abdominal | N | N | | | | | N | Note 1, Note2 |
| Intraoperative (specify)* | N | N | | | | | N | Note 2 |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | N | N | | | | | N | Note 1, Note 2 |
| Small organ (specify)** | N | N | | | | | N | Note 2 |
| Neonatal Cephalic | N | N | | | | | N | Note 2 |
| Adult Cephalic | N | N | | | | | N | Note 2 |
| Trans-rectal | N | N | | | | | N | Note 2 |
| Trans-vaginal | N | N | | | | | N | Note 2 |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card.) | | | | | | | | |
| Musculo-skeletal Conventional | N | N | | | | | N | Note 1, Note 2 |
| Musculo-skeletal Superficial | N | N | | | | | N | Note 2 |
| Intravascular | | | | | | | | |
| Cardiac Adult | N | N | | | | | N | Note 2 |
| Cardiac Pediatric | N | N | | | | | N | Note 2 |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | N | N | | | | | N | Note 2 |
| Other (specify)*** | N | N | | | | | N | Note 1, Note 2 |
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | | | | | | | | |
| Additional comments: Combined modes: B+M | | | | | | | | |
| *Intraoperative includes abdominal, thoracic, and vascular. | | | | | | | | |
| **Small organ-breast, thyroid, testes. | | | | | | | | |
| ***Other use includes Urology. | | | | | | | | |
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | |
| Note 2: Biopsy Guidance | | | | | | | | |

(PL&ASE DO NOT WATERS OW Achte 1.64 Concurrence of CDRE, Office of Device Evoluntion(ODE)

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Assan B. Goddstein-Falk

{6}------------------------------------------------

# 11/28/2011 00:01 FAX [phone]

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NOV. 29. 2011 1:44PM

Diagnostic Ultrasound Indications for Use Form Transchoer 赛

Frankshis Model:

51003) Number (3)

ACTICA

| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other<br>(specify) |
|----------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | P | Note 2 | |
| Abdominal | P | P | | | | | | |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | P | Note 2 |
| Pediatric | P | P | | | | | | |
| Small organ (specify)** | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card.) | | | | | | | | |
| Musculo-skeletal Conventional | P | P | | | | | P | Note 2 |
| Musculo-skeletal Superficial | | | | | | | | |
| Intravascular | | | | | | | P | Note 2 |
| Cardiac Adult | P | P | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | Note |
| Peripheral Vascular | P | P | | | | | P | |
| Other (specify)*** | | | | | | | | |
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | | | | | | | | |
| Additional comments: Combined modes: B+M | | | | | | | | |
| *Intraoperative includes abdominal, thoracic, and vascular. | | | | | | | | |
| **Small organ-breast, thyroid, testes. | | | | | | | | |
| ***Other use includes Urology. | | | | | | | | |
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | |
| Note 2: Biopsy Guidance | | | | | | | | |

(FLBASE DO NO NORH, Office of Doviev Evelastian(ODDE)

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# 11/29/2011 @0:01 FAX [phone]B46 NOV. 29. 2011 1:44PM

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### Diagnastic Ultrasound Indications for Use Barn Transduscr 개

System Model:

910();) Number(s)

35CSGRE - In 155

| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
|----------------------------------|---|---|-----|-----|------------------|----------------------|-----------------------|-----------------|
| Ophthalmic | | | | | | | | |
| Fetal | N | N | | | | | N | Note 1, Note 2 |
| Abdominal | N | N | | | | | N | Note 1, Note 2 |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | N | N | | | | | N | Note 1, Note 2 |
| Small organ(specify)** | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card.) | | | | | | | | |
| Musculo-skeletal<br>Conventional | N | N | | | | | N | Note 1, Note 2 |
| Musculo-skeletal Superficial | | | | | | | | |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph.(Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | | | | | | | | |
| Other (specify)*** | N | N | | | | | N | Note 1, Note 2 |

we other use includes Urology_ Note I: Tissue Hornonia limaging. The formers does not use contrast agents.

Note 2: Blapsy Guiduzes

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{8}------------------------------------------------

# 11/29/2011 00:02 FAX [phone] Susan D 1601Østein-Falker 1

Susan Q. Goldstein-Falk

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# 30V. 29. 2011 1:44PM

### Blagantic Ultrasound Indications for Use Form Trensdicer ×

| System<br>Modal: | 65EC10RB | | | | | | Transducer | |
|----------------------------------------------------------------------------|----------|---|-----|-----|------------------|----------------------|-----------------------|--------------------|
| 510(k) Number(s) | K43153 | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | Note 2 |
| Fetal | N | N | | | | | N | Note 2 |
| Abdominal | | | | | | | | |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | | | | | | | | |
| Small organ (specify)** | | | | | | | N | Note 2 |
| Neonatal Cephalic | N | N | | | | | N | Note 2 |
| Adult Cephalic | | | | | | | | Note 2 |
| Trans-rectal | N | N | | | | | N | Note 2 |
| Trans-vaginal | N | N | | | | | N | |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card.) | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph (Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | | | | | | | N | Note 2 |
| Other (specify)*** | N | N | | | | | | |
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | | | | | | | | |
| Additional comments: Combined modes: B+M. | | | | | | | | |
| *Intraoperative includes abdominal, thoracic, and vascular. | | | | | | | | |
| **Small organ-breast, thyroid, testes. | | | | | | | | |
| ***Other use includes Urology. | | | | | | | | |
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | |

Pressiption USE (Fer 21 CFR 80L 109)

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{9}------------------------------------------------

System

Dingmostic Clarasound Indications for Use Form Transdocket

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NOV. 29. 2011 1:44 PM

## uu. 1741

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| Model: | 65EL60EA |
|------------------|----------|
| 510(k) Number(s) | K113152 |

| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
|-------------------------------|---|---|-----|-----|---------------|-------------------|--------------------|-----------------|
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | | | | | | | | |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | | | | | | | | |
| Small organ(specify)** | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | P | P | | | | | P | Note 2 |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph(non-Card.) | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph(Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | P | P | | | | | P | Note 2 |
| Other(specify)*** | | | | | | | | |

New indication: P=previously cleared by FDA; E=added under Appendix E

Additional comments: Combined modes: B+M

*Intraoperative includes abdominal, thoracic, and vascular.

**Small organ=breast, thyroid, testis.

***Other can includes Urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Biopsy Guidance

Proscription USE (Por 21 CPR 801.109)

Division Sign-Off

Dogsino of Rad Chica

SIOK K112653

**0035**

----------------------------------------------------------------------

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# 11/29/2011 00.02 FAX [phone]

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Disquostic Ukrareand Indications for Use Form Trunsmoer - Se

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| | Mode of Operation | | | | | | | |
|----------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|--------------------|
| Clinical Application | B | M | FWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | N | Note 2 |
| Abdominal | N | N | | | | | | |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | N | Note 2 |
| Pediatric | N | N | | | | | | Note 2 |
| Small organs (specify)** | N | N | | | | | N | Note 2 |
| Neonatal Cephalic | N | N | | | | | | |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card.) | | | | | | | N | Note 2 |
| Musculo-skeletal Conventional | N | N | | | | | N | Note 2 |
| Musculo-skeletal Superficial | N | N | | | | | | |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | N | Note 2 |
| Peripheral Vascular | N | N | | | | | | |
| Other (specify)*** | | | | | | | | |
| N=new indication; P=previously cleared by FDA; *added under Appendix E | | | | | | | | |
| Additional comments: Combined modes: B+M. | | | | | | | | |
| *Intraoperative includes abdominal, thoracic, and vascular. | | | | | | | | |
| **Small organ-breast, thyroid, testes. | | | | | | | | |
| ***Other use includes Urology. | | | | | | | | |
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | |
| Note 2: Biopsy Guidance | | | | | | | | |

Copaurement of CDRH, Office of Device Evelusion(ODE)

Preseription USB (Per 21 CFR 801-109)

Aad OJK
(Citizen Sign-On)

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

sick K13153

0036

ਤਿੰਦਾ ਹੈ।

and and the state of the starter

:

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

11 - 11:41 - 11

{11}------------------------------------------------

ਾ ਦੀ ਸੀ।

,第二十

1947

| Symon<br>Model: | 751.53EA |
|------------------|----------|
| 510(k) Number(s) | K1/3153 |

| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other<br>(specify) |
|-------------------------------|---|---|-----|-----|------------------|----------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | P | P | | | | | P | Note 2 |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | P | P | | | | | P | Note 2 |
| Small organ(specify)** | P | P | | | | | P | Note 2 |
| Neonatal Cephalic | P | P | | | | | P | Note 2 |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph (non-Card) | | | | | | | | |
| Musculo-skeletal Conventional | P | P | | | | | P | Note 2 |
| Musculo-skeletal Superficial | P | P | | | | | P | Note 2 |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph (Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | P | P | | | | | P | Note 2 |
| Other (specify)*** | | | | | | | | |

N=new indication; P=previously cleared by FDA; B=added under Appendix E

Additional comments: Combined modes: B+M.

*Intraoperative includes abdominal, thoracic, and vascular.

**Small organ-breast, thyroid, testes.

***Other use includes Urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Biopsy Guidance

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRE, Office of Device Evaluation (ODE)

Proses prion USE (Por 21 CFR 801.109)

Mr. A. O. Dike

Division of Radiological Devices
Bureau of on Vitro Diagnostic Device Evaluation and Safety

sick E 113/51

0037

11 11:42 1

1135 - - 5 pharal Socied hat hand - a - a r d min 4 i = = ( . + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + +

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Allen and the

く:

13,100

Alley-uterspiros . 0 uesus

元年度时 8685526596 00 00 Proversity Search on the first the mind the mind the mail of the

.

{12}------------------------------------------------

# NOV. 29. 2011 3:13PW

이 대한 이상 등 1

and the comments of the comments of the comments of the

的主要最新的位置

ਸਿੰਘ ਸੀ। ਇਸ ਦੀ ਸਾਰੇ ਦੇ ਮੁ

ﺍﻟﻤﻮﺿﻮﻉ ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ

이 대한 사용

1941 - 1944

11,97

1

Diagnostic Ultrasound Indications for Use Form

| System | |
|------------------|----------|
| Model | TSLT3REA |
| 510(k) Number(s) | 5113153 |

Transducer

Mode of Operation

| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
|-------------------------------|---|---|-----|-----|---------------|-------------------|--------------------|-----------------|
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | P | P | | | | | P | Note 2 |
| Intraoperative (specify)* | P | P | | | | | P | Note 2 |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | P | P | | | | | P | Note 2 |
| Small organ (specify)** | P | P | | | | | P | Note 2 |
| Neonatal Cephalic | P | P | | | | | P | Note 2 |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph (non-Card.) | | | | | | | | |
| Musculo-skeletal Conventional | P | P | | | | | P | Note 2 |
| Musculo-skeletal Superficial | P | P | | | | | P | Note 2 |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph (Cardiac) | | | | | | | | |
| Trans-Cardiac | | | | | | | | |
| Peripheral Vascular | P | P | | | | | P | Note 2 |
| Other (specify)**** | | | | | | | | |

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional comments: Combined modes: B+M

*Intraoperative includes abdominal, thoracic, and vascular.

**Small organ-breast, thyroid, testes.

***Other use includes Urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note2: Biopsy Guidance

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CORE, Office of Device Evaluation (ODE)

Preseription USC (Per 21 CFR 801.109)

Arda D.K.
[signature]

Offica and Smary

DTOR K113153

0038 11:51 11

:

1 - 1

문의 대학교 대학

8985829898 88 FAJ BP Fra BP:00 FLO2762111 ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

{13}------------------------------------------------

# 11/28/2011 00:21 FAX [phone] XDV. 29. 2011 1:53PM

## 国001/014

P. 13/24 NO. 124 /

Dingnostia Ultrassund Indications for Use Form Transquaer

DP-30

11:316

- gyestu ?નવીધી:
510(g) Number(s)

| Clinical Application | B | M | FWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
|----------------------------------|---|---|-----|-----|------------------|----------------------|-----------------------|-----------------|
| Ophthalmic | N | N | | | | | N | Note 1, Note2 |
| Fetal | N | N | | | | | N | Note 1, Note2 |
| Abdominal | N | N | | | | | N | Note 2 |
| Intraoperative (specify)* | N | N | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | N | N | | | | | N | Note 1, Note 2 |
| Small organ(specify)** | N | N | | | | | N | Note 2 |
| Neonatal Cephalic | N | N | | | | | N | Note 2 |
| Adult Cephalic | N | N | | | | | N | Note 2 |
| Trans-rectal | N | N | | | | | N | Note 2 |
| Trans-vaginal | N | N | | | | | N | Note 2 |
| Trans-urethral | | | | | | | | |
| Trans-esoph(non-Card.) | | | | | | | N | Note 1, Note 2 |
| Musculo-skeletal<br>Conventional | N | N | | | | | N | Note 2 |
| Musculo-skeletal Superficial | N | N | | | | | | |
| Intravascular | | | | | | | N | Note 2 |
| Cardiac Adult | N | N | | | | | N | Note 2 |
| Cardiac Pediatric | N | N | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph.(Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | N | Note 2 |
| Peripheral Vascular | N | N | | | | | N | Note 1, Note 2 |
| Other (specify)*** | N | N | | | | | -N | Note 1, Note 2 |

**Intervention includes abdominal, thoracic, and**

- at Small ongag-breast, thyroid, tastes.
xxx (Jiber ust meludes Urolagy.

Note 1. Tissue Hornomio Ilmiging, The feature doos nor use nontrast agains.

Note I; Biopsy Guidence

810

(FLBASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
(FLBASE DO NOT WRITE BELLOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
(FLBASE DO NOT WRITE BELLOW Concurrante of CDRH, Office of Device Evalustian(ODE)

Prestoritstica USE (Par 21 CFR 801-109)

Marth D. Kirk

**Division Sign-Off**
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

{14}------------------------------------------------

Dingnoote Clerasound ladications for Use Form Tasistadiaat

# 欧002/014

P. 16/24

| System | 35C205A |
|------------------|---------|
| Model: | |
| 510(K) Number(s) | K113153 |

| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
|---------------------------------|---|---|-----|-----|---------------|-------------------|--------------------|-----------------|
| Ophthalmic | | | | | | | | |
| Femoral | | | | | | | | |
| Abdominal | P | P | | | | | P | Note 2 |
| Intraoperative (specify)* | | | | | | | | |
| Invasive/Interventional (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | P | P | | | | | P | Note 2 |
| Small organ(specify)** | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph (non-Card.) | | | | | | | | |
| Musculo-skeletal Conventional | P | P | | | | | P | Note 2 |
| Musculo-skeletal Superficial | | | | | | | | |
| Intravascular | | | | | | | | |
| Cardiac Adult | P | P | | | | | P | Note 2 |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph(Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | P | P | | | | | P | Note 2 |
| Other (specify)*** | | | | | | | | |

N=new indication: P=previously cleared by FDA; E=added under Appendix E

Additional comments: Combined modes: B+M.

*Intraoperative includes abdominal, thoracic, and vascular.

**Small organ-breast, thyroid, testes.

***Other use includes Urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Biopsy Guidance

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Presentpeion USE (Per 21 CPR 801.109)

ﻬﻢ ﺍﻟﻤﺘﺤﺪﺓ

Mashad R. J.M.

State As Subly office of the STITUTE ARD .

න්නේ පිහිටා විසින් පිහිටි බවට පිහිටි පිහිටි බවට පිහිටි පිහිටි බවට පිහිටි පිහිටි පිහිටි බවට පිහිටි පිහිටි පිහිටි බවට පිහිටි පිහිටි පිහිටි බවට පිහිටි පිහිටි පිහිටි බවට පිහිටි

SIOK K113/53

0040

.

{15}------------------------------------------------

## 11/28/2011 00.22 FAX [phone]

0003/014

## NOV. 29. 2011, 1:53PM

### Dingnostic Uttrasonad Indications for Use Form

Transdates *

System Modal: 510kk) Nizabea (s)

35 50RA 113157

| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
|----------------------------------|---|---|-----|-----|------------------|----------------------|-----------------------|-----------------|
| Ophthalmic | | | | | | | | |
| Fetal | P | P | | | | | P | Note 1, Note 2 |
| Abdominal | P | P | | | | | P | Note 1, Note 2 |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | P | P | | | | | P | Note 1, Note 2 |
| Small organs (specify)** | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card.) | | | | | | | | |
| Musculo-skeletal<br>Conventional | P | P | | | | | P | Note 1, Note 2 |
| Musculo-skeletal Superficial | | | | | | | | |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph.(Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | | | | | | | | |
| Other (specify) | P | P | | | | | P | Note 1, Note 2 |

Pressuiption USE (Par 21 CFR 801 109)

:

1. 2. No. 1. 1.

Ars. A. DDA
[Director Sign-Off]

Division of Realding and Dentose Office of In Unite Disamostic Device Element

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

k 11311 510K,

0041

{16}------------------------------------------------

# 11/29/2011 00:22 FAX [phone]

团 004/014

HCV. 29, 2011 1:59PM

### Diagagene Ultrasonnd Indications for Use Form antinas ਮ

System Modal: 510() Number (s)

| 65CLSEA |
|---------|
| 511315 |

| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other<br>(specify) |
|----------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | P | P | | | | | | Note 2 |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | P | Note 2 |
| Pediatric | P | P | | | | | | |
| Small organ(specify)** | | | | | | | P | Note 1 |
| Neonatal Cephalic | P | P | | | | | P | Note 2 |
| Adult Cephalic | P | P | | | | | P | Note 2 |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card.) | | | | | | | | |
| Musculo-skeletal Conventional | P | P | | | | | P | Note 2 |
| Musculo-skeletal Superficial | | | | | | | | |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | P | P | | | | | P | Note 2 |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | P | P | | | | | P | Note 2 |
| Other (specify)*** | | | | | | | | |
| Notes: Indication; P=previously cleared by FDA, E=added under Appendix E | | | | | | | | |
| Additional comments: Combined modes: B+M | | | | | | | | |
| *Intraoperative includes abdominal, thoracic, and vascular. | | | | | | | | |
| **Small organ-breast, thyroid, testes. | | | | | | | | |
| ***Other are includes Urology. | | | | | | | | |
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | |
| Note 2: Biopsy Guidance | | | | | | | | |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | | | | | | | | |

Presentption USB (Per 21 CFR 80J.109)

، • • ﺳﻢ

Puss D'H

Oversion of Radiolor Citics of in Boon gives Sinters

**6103/53**

{17}------------------------------------------------

# 11/28/2011 00.22 Fax [phone] NOV. 29. 2011 1:59PM

1974 - 1

## NU. 1241 - 124 11/24

团 005/014

이 지원할 수

3. 2.3.2.2.11 3-1131

| Diagnostic Ultrasound Indications for Use Form |
|------------------------------------------------|
| Transducer |
| 65PC10EA |

K 113123

Model: 510(k) Number(s)

System

.

1, 201

在线上

我要的一个人

| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other<br>(specify) |
|----------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|-----------------------|--------------------|
| Ophthalmic | P | P | | | | | P | Note 2 |
| Fetal | | | | | | | | |
| Abdominal | | | | | | | | |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | | | | | | | | |
| Small organ (specify)** | | | | | | | | |
| Neonatal Cephalic | P | P | P | | | | P | Note 2 |
| Adult Cephalic | | | | | | | | |
| Transrectal | P | P | | | | | P | Note |
| Trans-vaginal | P | P | | | | | P | Note |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card.) | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph.(Cardiac)…